Inspiration Hlt Regulatory News (IHC)

Inspiration Healthcare Group plc

 ("Inspiration Healthcare", the "Company" or the "Group")

Project WAVE - IRAS submission

Inspiration Healthcare Group plc (AIM: IHC), the global medical technology company is pleased to announce that it has submitted an application through the Integrated Research Approval System (IRAS) for trials to begin for the respiratory device it has designed for use in neonatal intensive care known as Project WAVE. The technology for Project WAVE was acquired by Inspiration Healthcare under licence in 2018 from a leading U.S. West Coast University and was granted a patent by the U.S. Patent Office as was announced on 25 March 2020.

The IRAS submission requests permission for the trial to begin at the Trevor Mann Baby Unit, Brighton & Sussex University Hospital (Royal Sussex). The application will be reviewed by The Medicines and Healthcare products Regulatory Agency (MRHA), Research Ethics Committee (REC) and Health Research Authority (HRA) to allow a non-C.E. marked device to be used under trial conditions.

Project WAVE received a grant towards the cost of this trial under the Med Tech Trials Innovation Support Grant scheme (MTT-ISG), awarded on 11 June 2020 by the Academic Health Science Networks (AHSN). The MTT-ISG grant is funded by the European Regional Development Fund (ERDF) who will contribute up to 50% (£50,000 maximum) towards the costs of this trial.

Neil Campbell, Chief Executive Officer, commented: "We are pleased to have submitted this application and moving the project on to the next phase. The Project WAVE device we have developed incorporates the latest findings in neonatal respiration from a leading U.S. West Coast University with Inspiration Healthcare's experience and knowledge in designing and manufacturing neonatal devices which improve medical outcomes. Once our submission gets the green light, which we expect in a few months, we look forward to working with the team at the Royal Sussex and getting the project one step closer to fruition."

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About Inspiration Healthcare http://www.inspiration-healthcare.com

Inspiration Healthcare (AIM: IHC) is a global provider of medical technology for use in critical care & operating theatres. The Company provides high-quality, innovative products to patients around the world which help to improve patient outcomes, and it actively invests in innovative product opportunities and disruptive technologies.

Through investment in research and development the Company has six key own-brand products that can be used within the first 6 hours of life to help premature and sick babies; helping with assessment, resuscitation, stabilisation as well as preventing brain damage. Additionally, the Company has a range of products for maintaining normothermia pre- during and post-surgery.

In September 2019, the Company acquired Vio Holdings a designer, manufacturer and supplier of single-use respiratory products and sterile medical consumables for £4 million and in June 2020 the Company acquired SLE, a leading global provider of neonatal ventilation products for £18 million.   Over 90% of SLE's revenues are generated from sales outside of the UK with a significant proportion of these in the Asia Pacific and the Middle East. When combined, the Group generates approximately 60 per cent. of its revenue from exports.

With product availability extending to over 50 countries through a distribution network, Inspiration Healthcare's success has been built on continuous innovation, excellent customer service and an inherent commitment to improving patient outcomes, working in close collaboration with key opinion leaders across the globe.

In the .K.U.K. and Ireland, the Company has a direct sales team selling Inspiration Healthcare Branded and complementary products from third parties, with an additional range of home healthcare products. This is supported by Technical Support for planned preventative maintenance and emergency assistance.

Further information on Inspiration Healthcare can be seen at www.inspiration-healthcare.com